§ 02 — Comparison

Compare regulatory pathways side-by-side

Benchmark MAHMAH, GMPGMP, HTAHTA and pathway requirements across up to three markets.

Country A

Country B

Country C

Highlight differences

Criterion	🇵🇭Philippines	🇬🇧United Kingdom
Authority & dossier
Regulatory authority	FDA Philippines (CDRR)	MHRA
English submissions	Yes	Yes
CTD accepted	Yes	Yes
eCTD accepted	No	Yes
Reliance pathway	Available	Available
Reference agencies	FDA (US), EMA, MHRA (UK), Health Canada +4	FDA, EMA, Health Canada, Swissmedic +4
Lead pathway (timeline & fees) — Initial Registration — Standard Review · International Recognition Procedure (IRP)
Pathway name	Initial Registration — Standard Review	International Recognition Procedure (IRP)
Approval timeline	365–730 days	60–110 days
Application fee	PHP 30,000	GBP 35,305
Annual renewal	PHP 0	GBP 0
Local representative	Required	Not required
Local manufacturing	Not required	Not required
GMP inspection	Required	Not required
MAH & local presence
Local entity required	Yes	Yes
Local responsible person	Yes	Yes
RP role	LTO holders must designate a Qualified Person (typically a registered pharmacist) responsible for the licensed premises, and a Qualified Person for Pharmacovigilance (QPPV) as the contact for FDA's Pharmacovigilance Division.	Qualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.
Accelerated pathways
Designations available	3 designations	4 designations
Examples	Facilitated Registration Pathway — Abridged & Verification Review, Emergency Use Authorisation (EUA), Conditional / Monitored Release Registration	Early Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1
Post-approval lifecycle
Variations framework	Variations classified per FDA Circulars (aligned with ASEAN Variation Guideline) into Major Variation (FDA approval), Minor Variation (prior approval or notification) and Administrative Variation. Renewal Data Capture (RDC) modernised the renewal workflow under the eRegistration system.	Variations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.
Renewal cycle	CPR is initially valid for 5 years and renewable for 5 years; renewal via Renewal Data Capture (RDC) under the modified eRegistration system, with up-to-date CMC, safety and labelling information.	Initial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.
Pharmacovigilance	FDA's Pharmacovigilance Division coordinates national ADR reporting (the Philippines is a member of the WHO Programme for International Drug Monitoring, Uppsala). CPR holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances and vaccines.	MHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.
Unlicensed access
Named Patient Supply	Available	Available
Compassionate Use	Available	Available
Emergency Import	Available	Available
Parallel Import	Not permitted	Permitted
Clinical trials
CTA approval	Required	Required
Ethics approval	Yes	Yes
CTA timeline	60–120 days	30–60 days
GCP standard	ICH E6(R2) GCP; FDA Philippines Good Clinical Practice guidelines and Philippine Council for Health Research and Development (PCHRD) National Ethical Guidelines	ICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)
Pricing & reimbursement
Price regulation	Regulated	Regulated
Reference pricing	No	No
HTA required	Yes	Yes
HTA body	Health Technology Assessment Council (HTAC) under the Universal Health Care Act (RA 11223, 2019)	NICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)

Verdict colours indicate lower, moderate, or higher regulatory burden — they're not value judgements on a market.

Authority & dossier

Regulatory authority

PhilippinesFDA Philippines (CDRR)
United KingdomMHRA

English submissions

PhilippinesYes
United KingdomYes

CTD accepted

PhilippinesYes
United KingdomYes

eCTD accepted

PhilippinesNo
United KingdomYes

Reliance pathway

PhilippinesAvailable
United KingdomAvailable

Reference agencies

PhilippinesFDA (US), EMA, MHRA (UK), Health Canada +4
United KingdomFDA, EMA, Health Canada, Swissmedic +4

Lead pathway (timeline & fees) — Initial Registration — Standard Review · International Recognition Procedure (IRP)

Pathway name

PhilippinesInitial Registration — Standard Review
United KingdomInternational Recognition Procedure (IRP)

Approval timeline

Philippines365–730 days
United Kingdom60–110 days

Application fee

PhilippinesPHP 30,000
United KingdomGBP 35,305

Annual renewal

PhilippinesPHP 0
United KingdomGBP 0

Local representative

PhilippinesRequired
United KingdomNot required

Local manufacturing

PhilippinesNot required
United KingdomNot required

GMP inspection

PhilippinesRequired
United KingdomNot required

MAH & local presence

Local entity required

PhilippinesYes
United KingdomYes

Local responsible person

PhilippinesYes
United KingdomYes

RP role

PhilippinesLTO holders must designate a Qualified Person (typically a registered pharmacist) responsible for the licensed premises, and a Qualified Person for Pharmacovigilance (QPPV) as the contact for FDA's Pharmacovigilance Division.
United KingdomQualified Person (Pharmacovigilance) — QPPV — must reside in the UK or EEA. UK Responsible Person (Import) for batch certification of products imported into GB. Local pharmacovigilance contact in the UK required for risk minimisation activities.

Accelerated pathways

Designations available

Philippines3 designations
United Kingdom4 designations

Examples

PhilippinesFacilitated Registration Pathway — Abridged & Verification Review, Emergency Use Authorisation (EUA), Conditional / Monitored Release Registration
United KingdomEarly Access to Medicines Scheme (EAMS), Conditional Marketing Authorisation, Authorisation under Exceptional Circumstances +1

Post-approval lifecycle

Variations framework

PhilippinesVariations classified per FDA Circulars (aligned with ASEAN Variation Guideline) into Major Variation (FDA approval), Minor Variation (prior approval or notification) and Administrative Variation. Renewal Data Capture (RDC) modernised the renewal workflow under the eRegistration system.
United KingdomVariations classified per UK Variations Regulations (mirroring EU Reg 1234/2008): Type IA, IAIN, IB, II, and Extensions. MHRA Worksharing available for grouped variations across multiple authorisations.

Renewal cycle

PhilippinesCPR is initially valid for 5 years and renewable for 5 years; renewal via Renewal Data Capture (RDC) under the modified eRegistration system, with up-to-date CMC, safety and labelling information.
United KingdomInitial 5-year renewal; thereafter MA is granted for unlimited duration unless MHRA determines on PV grounds that one further 5-year renewal is justified.

Pharmacovigilance

PhilippinesFDA's Pharmacovigilance Division coordinates national ADR reporting (the Philippines is a member of the WHO Programme for International Drug Monitoring, Uppsala). CPR holders must submit PSURs aligned to ICH E2C(R2), report serious ADRs within statutory timelines, and maintain a Risk Management Plan (RMP) for new active substances and vaccines.
United KingdomMHRA operates the Yellow Card Scheme for ADR reporting. PSURs follow the EU Reference Date list pre-Brexit, with MHRA UK-specific PSUR list since 2021. RMPs required for new MAs and significant variations. Black triangle (▼) for additional monitoring.

Unlicensed access

Named Patient Supply

PhilippinesAvailable
United KingdomAvailable

Compassionate Use

PhilippinesAvailable
United KingdomAvailable

Emergency Import

PhilippinesAvailable
United KingdomAvailable

Parallel Import

PhilippinesNot permitted
United KingdomPermitted

Clinical trials

CTA approval

PhilippinesRequired
United KingdomRequired

Ethics approval

PhilippinesYes
United KingdomYes

CTA timeline

Philippines60–120 days
United Kingdom30–60 days

GCP standard

PhilippinesICH E6(R2) GCP; FDA Philippines Good Clinical Practice guidelines and Philippine Council for Health Research and Development (PCHRD) National Ethical Guidelines
United KingdomICH E6(R3) (MHRA adopted via Good Clinical Practice Guide; UK statutory instruments 2004/1031 as amended)

Pricing & reimbursement

Price regulation

PhilippinesRegulated
United KingdomRegulated

Reference pricing

PhilippinesNo
United KingdomNo

HTA required

PhilippinesYes
United KingdomYes

HTA body

PhilippinesHealth Technology Assessment Council (HTAC) under the Universal Health Care Act (RA 11223, 2019)
United KingdomNICE (England, Wales, NI), SMC (Scotland), AWMSG (Wales)